The Phase I clinical trial was initiated to evaluate the safety, tolerability and pharmacokinetics of ON 01210.Na in healthy volunteers. Data from this initial trial will be used to design larger studies to provide safety profile for approval purposes.
A radiation protection drug for both prophylactic and therapeutic applications, ON 01210.Na is a modulator of DNA repair pathways and has been shown to enhance survival in animal models of radiation injury. The drug is being developed under the FDA’s animal rule which outlines the approval pathway for drugs indicated for protection against harmful agents, including radiation.
Manoj Maniar, senior vice president of product development at Onconova, said: “This program is the result of a successful collaboration between our scientists and the researchers at the Armed Forces Radiobiology Research Institute (AFRRI), a Department of Defense organization whose mission includes research on the prevention and treatment of radiation injuries.”